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DURECT Corporation Announces First Quarter 2011 Financial Results and Update of Programs
Date:5/5/2011

nt class-wide REMS announcement for extended release opioids.  Pfizer stated that these issues could delay the timing of approval or the launch of REMOXY.  As a result of its acquisition of King, Pfizer has assumed the development and commercialization rights and obligations to REMOXY.  

REMOXY, an investigational drug, is a unique long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT's ORADUR® technology, which is covered by issued patents and pending patent applications owned by us, REMOXY is designed to resist common methods of prescription drug misuse and abuse.   An abuse liability study was recently published in Pain Medicine, the Official Journal of the American Academy of Pain Medicine.  In this study of REMOXY versus Oxycodone ER tested in volunteers with a history of opioid abuse, REMOXY met all prospectively defined primary endpoints.  See "The Abuse Potential of Remoxy®, an Extended-Release Formulation of Oxycodone, Compared with Immediate- and Extended-Release Oxycodone" (Pain Medicine 2011; 12; 618-631).  This study complements previously published data on the extraction under various conditions of oxycodone from REMOXY; see "Remoxy®: A Novel Formulation of Extended-Release Oxycodone Developed Using the ORADUR® Technology" (The Journal of Applied Research, Vol.10, No.3, 2010)  which is accessible on DURECT's website at www.durect.com/wt/durect/page_name/Publications.

  • POSIDUR (SABER™-Bupivacaine) Post-Operative Pain Relief Depot. During the first quarter of 2011, we continued enrolling patients in our U.S. pivotal Phase III clinical study known as BESST (Bupivacaine Effectiveness and Safety in SABER Trial).  We expect to complete enrollment of BESST, comprising approximat
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